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The Clinical Study of Synaptic Plasticity-based Lencanumab for the Treatment of Early Alzheimer's Disease
Lead sponsor
Asset
Lecanemab
Listed sites
1
Recruiting sites
1
Enrollment
120
estimated
Study population
Alzheimer’s disease
Key I/E criteria
•Amyloid biomarker required (PET/CSF)•MMSE ≥20•Study partner/caregiver required•MRI contraindications excluded•History of intracranial hemorrhage excluded
Primary endpoint
•Resting-state fMRI brain network metrics
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Age between 50 and 90 years.
2. Male or female patients.
3. Patients with MCI and mild AD.
4. MMSE score ≥20, CDR overall score of 0.5 or 1.
5. Amyloid-positive confirmed by Amyloid-PET or CSF.
6. Have a reliable caregiver to accompany the patient during study visits and supervise the use of study medication during the trial.
7. Agree to participate in the study and sign the informed consent form
Exclusion criteria
1. Patients with cognitive impairment due to reasons other than AD.
2. A history of transient ischemic attack (TIA), stroke, cerebral hemorrhage, or seizure within the 12 months prior to screening.
3. A score of >17 on the Hamilton Depression Scale at screening, or any suicidal behavior within 6 months prior to screening, at screening, or at the baseline visit, as well as any psychiatric diagnosis or symptoms that interfere with the study procedure (such as hallucinations, anxiety disorder, or paranoia).
4. Patients with a bleeding disorder or receiving anticoagulant therapy, as well as any with malignant tumors, severe gastrointestinal, kidney, liver, respiratory, immune, endocrine, and cardiovascular system diseases that affect this study.
5. A hypersensitivity reaction to ranucimab or any other ingredient in the injection solution, or to any monoclonal antibody treatment.
6. Contraindications to MRI scanning, including those with a pacemaker/defibrillator or ferromagnetic metal implants (except for skull and cardiac devices approved as safe for MRI scanning).
7. A known or suspected history of drug or alcohol abuse or dependence within the 2 years prior to screening.
8. Participation in a clinical study involving any therapeutic monoclonal antibody or novel compounds for the treatment of AD within the 6 months prior to screening, unless it can be proven that the subject was in the placebo treatment group.
9. Planning to undergo surgery requiring general anesthesia during the study period.
10. A positive pregnancy test result, lactation, or pregnancy in females at screening or baseline.
Endpoints (21)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Global cognition
4 endpointsRate of change in global cognition as measured by Clinical Dementia Rating (CDR)
Time frame:2 years
change from baseline, improvement
Rate of change in the severity of cognitive impairment as assessed by Alzheimer's Disease Assessment Scale-Cognitive section (ADAS-cog)
Time frame:2 years
ADAS-Cog
change from baseline, improvement
Rate of change in global cognition as measured by Mini-Mental State Examination (MMSE)
Time frame:2 years
Mini-Mental State Examination (MMSE)
change from baseline, improvement
Rate of change in global cognition as measured by Montreal Cognitive Assessment (MoCA)
Time frame:2 years
Montreal Cognitive Assessment (MoCA)
change from baseline, improvement
Function / daily living
2 endpointsThe Integrated Alzheimer's Disease Rating Scale (iADRS)
Time frame:2 years
ADAS-Cog
descriptive
Rate of change in activities of daily living as assessed by Alzheimer's Disease Cooperative Study-Activity of Daily Living (ADCS-ADL)
Time frame:2 years
ADCS-Activities of Daily Living (ADCS-ADL)
change from baseline, improvement
Behavior / neuropsychiatric
4 endpointsFive Levels Five-Dimensional Health Scale (EQ-5D-5L)
Time frame:2 years
descriptive
Rate of change in psychobehavioral symptoms as assessed by Neuropsychiatric Inventory (NPI)
Time frame:2 years
Neuropsychiatric Inventory (NPI)
change from baseline, improvement
Hamilton Anxiety Scale (HAMA)
Time frame:2 years
ratio, descriptive
Hamilton Depression Rating Scale (HAMD)
Time frame:2 years
descriptive
Amyloid biomarkers
2 endpointsBlood AD molecular pathology and synaptic structural protein content indicators
Time frame:2 years
Phosphorylated tau 217 (p-tau217)
concentration, descriptive
Neuroimaging biomarkers: Aβ-PET centiloid values
Time frame:2 years
Amyloid PET Centiloid
descriptive
Neurodegeneration biomarkers
1 endpointCerebrospinal Fluid Synaptic Function Protein Content Assessment Indicator
Time frame:2 years
concentration, descriptive
Neuroimaging
4 endpointsResting-state fMRI brain network metrics (Independent Component Analysis)
Time frame:2 years
descriptive
Other resting-state fMRI brain network indicators: functional connectivity (FC)
Time frame:2 years
descriptive
Other resting-state fMRI brain network indicators: Granger Causality Analysis (GCA)
Time frame:2 years
descriptive
Other resting-state fMRI brain network indicators: Spectral Dynamic Causal Model (spDCM)
Time frame:2 years
descriptive
Caregiver / quality of life
2 endpointsAlzheimer's Disease Quality of Life Scale (QOL-AD)
Time frame:2 years
descriptive
Zarit Caregiver Burden Interview Scale (ZBI)
Time frame:2 years
descriptive
Other (unclassified)
2 endpointsAlzheimer's Disease Composite Score (ADCOMS)
Time frame:2 years
descriptive
Blood neuron-derived exosome transcriptomics-related indicators
Time frame:2 years
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.